Clinical trial

Double Trigger and Ovum Retrieval vs. Conventional Antagonist Ovarian Stimulation Protocol in Poor Prognosis Women Undergoing IVF/ICSI: A Pilot Randomized Study

Name

58335

Description

The purpose of this randomized pilot study is to compare the efficacy of double oocyte retrieval vs. conventional antagonist ovarian stimulation protocol in poor prognosis patients undergoing in vitro fertilization (IVF) or intra-cytoplasmic sperm injection (ICSI).

Trial arms

Trial start

2019-10-01

Estimated PCD

2021-09-15

Trial end

2022-10-01

Status

Completed

Phase

Early phase I

Treatment

Corifollitoropin alfa (CFA)-double pick up

In the study group, 225 IU of recombinant FSH (rFSH) will continue after the first oocyte retrieval (OR). Antagonist administration will be initiated when at least one follicle measuring ≥14 mm will be present in the ultrasound. If one or more follicles ≥17 mm are observed, patients will undergo a second triggering with human chorionic gonadotropin (hCG) 5000 IU and a second OR will be performed. In case of patients with no follicular development following 10 additional days of rFSH post-OR

Arms:

double pick up group

Size

Primary endpoint

Number of MII Oocytes Retrieved Between the Two Arms

1 month

Eligibility criteria

Inclusion Criteria: * Age 25-40 years * Body mass index (BMI) ≤ 35 and ≥ 19 * Antimüllerian hormone (AMH) level of ≤1.5 ng/mL or antral follicular count (AFC) of ≤6 follicles or ≤5 oocytes retrieved in a previous cycle following standard conventional ovarian stimulation. Exclusion Criteria: * Testicular sperm extraction * History of \> 3 three consecutive previous unsuccessful IVF cycles * BMI \>35 or \<19 * Use of oral contraceptives \<3 months before start of the treatment * polycystic ovary syndrome (PCOS) according to the Rotterdam criteria * Ovarian stimulation for pre-implantation genetic testing (PGT-A/M) * Medical/social freezing * In vitro maturation (IVM) * History of untreated autoimmune, endocrine or metabolic disorders, * Ovarian cystectomy or oophorectomy

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['CARE_PROVIDER', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 48, 'type': 'ACTUAL'}}

Updated at

2024-05-21

1 organization

1 product

1 indication

Organization

CRG UZ Brussel

Product

Corifollitoropin alfa

Indication

Fertility Disorders